Deep brain stimulation of the thalamus for intractable epilepsy (FRANCE study): A randomized clinical trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: OBJECTIVE: This study was undertaken to evaluate the efficacy and safety of deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) compared with best medical treatment (BMT) in patients with drug-resistant epilepsy (DRE). METHODS: This randomized, open-label, phase 3 controlled trial was conducted across 14 specialized epilepsy and DBS centers. Eligible participants were adults with focal or multifocal DRE who had previously failed vagus nerve stimulation (VNS). Sixty-one patients were randomized 1:1 either to receive continuous bilateral ANT-DBS (n = 30) or to continue BMT, including VNS (n = 31), for 12 months. Afterward, patients in the BMT group were offered delayed ANT-DBS and followed for an additional year. The primary outcome was the change in monthly severe seizure frequency (defined on the modified Chalfont Scale) at 12 months. Safety outcomes were also recorded. RESULTS: Among 67 screened patients, 61 were enrolled. At 12 months, median seizure reduction was greater in the DBS group (-44%, interquartile range [IQR] = -67 to 0) versus the BMT group (-6%, IQR = -56 to 20; p = .09); 44.5% of patients in the DBS group achieved a ≥50% reduction in seizure frequency compared to 27% in the BMT group. Within-group analyses showed significant seizure reductions in the DBS group at both 12 months (-44%, p < .001) and 24 months (-46%, p < .001), as well as in the delayed DBS group at 12 months (-36%, IQR = -73 to -4; p < .001). No significant differences in quality of life were observed between groups, and no major DBS-related adverse events were reported. SIGNIFICANCE: Our study suggests a potential benefit rather than demonstrating superiority of ANT-DBS over medical therapy. However, within-group improvements and favorable safety profile support the use of ANT-DBS as a palliative treatment option in patients with DRE who have failed VNS.
Source: Epilepsia
DOI: 10.1002/epi.70211
Authors: Stéphan Chabardès, Fabrice Bartolomei, Anca Nica, Claire Haegelen, Lorella Minotti, Brigitte Piallat, Chrystele Mosca, Sandrine Massicot, Sylvain Rheims, Marc Guenot, Emmanuel Cuny, Jérome Aupy, Louis Maillard, Sophie Colnat‐Coulbois, Corentin Leroy, Romain Carron, Philippe Coubes, Philippe Gélisse, Carine Karachi, Vincent Navarro, Bertrand Devaux, Francine Chassoux, Phlippe Derambure, Nicolas Reyns, Jean Christope Sol, Luc Valton, Denys Fontaine, Veronique Bourg, Philippe Kahane, Sandra David‐Tchouda, Jean Regis
Institutions: Inserm, Centre Hospitalier Universitaire de Grenoble, Clinatec, Grenoble Institute of Neurosciences, Université Grenoble Alpes, Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone, Laboratoire Traitement du Signal et de l'Image, CIC Rennes, Centre Hospitalier Universitaire de Rennes, Université de Rennes, Institut polytechnique de Grenoble, Centre National de la Recherche Scientifique, Translational Innovation in Medicine and Complexity, Lyon 1 Université, Hospices Civils de Lyon, Hôpital Pierre Wertheimer, Université de Bordeaux, Centre Hospitalier Universitaire de Bordeaux, Institut des Maladies Neurodégénératives, Centre Hospitalier Régional et Universitaire de Nancy, Ingénierie Moléculaire, Cellulaire et Physiopathologie, Université de Lorraine, Centre Hospitalier Universitaire de Montpellier, Hôpital Gui de Chauliac, Sorbonne Université, Pitié-Salpêtrière Hospital, Institut du Cerveau, Hôpital Lariboisière, Centre Hospitalier Universitaire de Lille, Lille Neurosciences & Cognition, Université de Lille, Centre de recherche cerveau et cognition, Université Côte d'Azur, Aix-Marseille Université
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,360
OpenAlex ID: W7142354466